The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Reusable Cw Doppler Probes: Models P8m05s8a, P8m05n5a, & Lcw-8.
| Device ID | K934638 |
| 510k Number | K934638 |
| Device Name: | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 |
| Classification | Transducer, Ultrasonic |
| Applicant | KOVEN TECHNOLOGY, INC. 300 BROOKES DR. SUITE 105 St. Louis, MO 63042 |
| Contact | Paul G Koven |
| Correspondent | Paul G Koven KOVEN TECHNOLOGY, INC. 300 BROOKES DR. SUITE 105 St. Louis, MO 63042 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-24 |
| Decision Date | 1994-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894912002883 | K934638 | 000 |
| 00894912002449 | K934638 | 000 |
| 00894912002425 | K934638 | 000 |
| 00894912002388 | K934638 | 000 |
| 00894912002371 | K934638 | 000 |
| 00894912002364 | K934638 | 000 |
| 00894912002357 | K934638 | 000 |
| 00894912002340 | K934638 | 000 |
| 00894912002333 | K934638 | 000 |
| 00894912002319 | K934638 | 000 |
| 00894912002302 | K934638 | 000 |
| 00894912002456 | K934638 | 000 |
| 00894912002937 | K934638 | 000 |
| 00894912002890 | K934638 | 000 |
| 00894912002876 | K934638 | 000 |
| 00894912002715 | K934638 | 000 |
| 00894912002708 | K934638 | 000 |
| 00894912002555 | K934638 | 000 |
| 00894912002418 | K934638 | 000 |
| 00894912002401 | K934638 | 000 |
| 00894912002395 | K934638 | 000 |
| 00894912002289 | K934638 | 000 |
| 00894912002975 | K934638 | 000 |
| 00894912002296 | K934638 | 000 |